Frozen Embryo Transfer (FET) in Natural Cycles or in Natu... | NCT00809107

Studies
Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration

NCT00809107

Sponsor

Universitair Ziekenhuis Brussel

Status

Completed

Last Update Posted

Feb 19, 2009Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Jul 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Dec 16, 2008

First Submission Date that Met QC Criteria

Dec 16, 2008

First Posted Date

Dec 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2009

Last Update Posted Date

Feb 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The rational of the study is to assess the implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and ovulation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	HCG GROUP	Drug: HCG
2	No Intervention	LH pick

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCG	Drug	5000IU	1	pregnyl

Measure	Description	Time Frame
Implantation rate		2 years

Measure	Description	Time Frame
Ongoing pregnancy rate		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age <40
BMI:18-29Kg/m2
day 3 embryo transfers
previously IVF or ICSI

Exclusion Criteria:

irregular cycles
oocyte donation cycles

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre of Reproductive Medicine		Brussels		1090	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16500326	Background	Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists